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HST.939 Designing and Sustaining Technology Innovation for Global Health Practice Spring 2008

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Everything You Ever Wanted Everything You Ever Wanted to Know About Medical Device to Know About Medical Device

Marketing ClearanceMarketing Clearance

Robert Phillips, Ph.D.Robert Phillips, Ph.D.Chief, Radiological Devices BranchChief, Radiological Devices Branch

Office of Device EvaluationOffice of Device EvaluationCenter for Devices and Radiological HealthCenter for Devices and Radiological Health

FDAFDA

[email protected]@cdrh.fda.gov

OutlineOutline

Sources of InformationSources of InformationStatutory BasisStatutory BasisRoutes to Market (Clearance Routes to Market (Clearance Processes)Processes)Investigational UseInvestigational UseSubmission FeesSubmission Fees

ContactsContactsWeb site: WWW.FDA.GOV/CDRHWeb site: WWW.FDA.GOV/CDRHDivision of Small Manufacturers Division of Small Manufacturers Assistance: 1Assistance: 1--800800--638638--20412041Program Operations Staff; IDE, 510(k), Program Operations Staff; IDE, 510(k), PMA: (301) 594PMA: (301) 594--11901190Radiology Branch: (301) 594Radiology Branch: (301) 594--12121212For For PostPost--market reporting: market reporting: MedWatchMedWatch: 1: 1--800800--FDAFDA--10881088

Useful PagesUseful Pages

Device AdviceDevice AdviceGuidance DocumentsGuidance DocumentsVoluntary StandardsVoluntary StandardsObtain Market Clearance / Obtain Market Clearance / ApprovalApproval

Medical Device AmendmentsMedical Device Amendments

May 28, 1976May 28, 1976

Role of FDARole of FDA

Establish Establish reasonablereasonableassurance of the safety and assurance of the safety and

effectiveness of medical effectiveness of medical devices marketed devices marketed

in the U.S.in the U.S.

Statutory Basis:Statutory Basis:Federal Food, Drug, and Cosmetic Federal Food, Drug, and Cosmetic

ActActAs amended byAs amended by::

Medical Device AmendmentsMedical Device Amendments--19761976–– Devices ClassifiedDevices Classified

Safe Medical Device Act (SMDA)Safe Medical Device Act (SMDA)--19901990–– Expanded roleExpanded role–– More detailMore detail

FDA Modernization ActFDA Modernization Act--19971997–– Redefined (more circumscribed) roleRedefined (more circumscribed) role–– More interactive with sponsorsMore interactive with sponsors–– Expanded/earlier access of new technologies to Expanded/earlier access of new technologies to

patientspatients

Statutory Basis:Statutory Basis:Federal Food, Drug, and Cosmetic Federal Food, Drug, and Cosmetic

Act (2)Act (2)

Medical Device User Fee and Medical Device User Fee and Modernization Act (MDUFMA) of 2002Modernization Act (MDUFMA) of 2002–– User feesUser fees–– Review time goalsReview time goals

Medical DeviceMedical DeviceAn instrument, apparatus, implement, machine, contrivance, An instrument, apparatus, implement, machine, contrivance,

implant, in vitro reagent, or other similar or related article, implant, in vitro reagent, or other similar or related article, including including any component, part, or accessory, which is:any component, part, or accessory, which is:

1) intended for use in the diagnosis of disease or other conditi1) intended for use in the diagnosis of disease or other conditions, ons, or in the cure, mitigation, treatment, or prevention of disease or in the cure, mitigation, treatment, or prevention of disease in in man, or 2) intended to affect the structure or any function of tman, or 2) intended to affect the structure or any function of the he

body of man, andbody of man, and

which does not achieve its primary which does not achieve its primary intended purposes through chemical intended purposes through chemical

action within or on the body of man and action within or on the body of man and which is not dependent upon being which is not dependent upon being

metabolized for the achievement of its metabolized for the achievement of its primary intended purposesprimary intended purposes..Section 201, Food Drug and Cosmetic ActSection 201, Food Drug and Cosmetic Act

Medical Device Approval Medical Device Approval ProcessProcess

Most devices on market prior to May 28, Most devices on market prior to May 28, 1976 were 1976 were ““grandfatheredgrandfathered””Marketing clearance for these devices Marketing clearance for these devices through 510(k) clearance processthrough 510(k) clearance process----Substantially EquivalentSubstantially Equivalent510(k)d devices are 510(k)d devices are notnot approvedapprovedMost radiological products on market Most radiological products on market using this processusing this process

Routes to MarketRoutes to Market

Premarket SubmissionPremarket Submission––501(k)501(k)

Premarket Approval ApplicationPremarket Approval Application––PMAPMA

Grandfathered DevicesGrandfathered Devices

Pre 1976 devices placed into three Pre 1976 devices placed into three classesclasses

––Class IClass I-- General controlsGeneral controls––Class IIClass II-- Special controlsSpecial controls––Class IIIClass III-- PMAPMA

Class IClass I

Low risk devicesLow risk devicesSafety and effectiveness assured bySafety and effectiveness assured by–– Good Manufacturing PracticesGood Manufacturing Practices–– PostPost--marketing surveillancemarketing surveillance–– Registration and listingRegistration and listing

Class IIClass II

Class I controls plusClass I controls plus““Special controlsSpecial controls””–– Voluntary standardsVoluntary standards–– Mandatory standardsMandatory standards–– GuidanceGuidance–– Manufacturing inspectionManufacturing inspection

Class IIIClass III

Premarket approval application that Premarket approval application that establishes Safety and Effectivenessestablishes Safety and Effectiveness

510(k)510(k)

Substantially Equivalent Substantially Equivalent –– New device is New device is compared to a similar device that is on the compared to a similar device that is on the market.market.Device need be only as good (or bad) as what Device need be only as good (or bad) as what was on market in 1976was on market in 1976510(k) clearance 510(k) clearance does notdoes not assure effectivenessassure effectivenessMany devices are exempt from 510(k) Many devices are exempt from 510(k) submissionsubmissionReview time about 90 daysReview time about 90 days

Medical Device Approval Medical Device Approval ProcessProcess

Devices that sustain life, implants, in Devices that sustain life, implants, in class III, or can not be shown class III, or can not be shown substantially equivalent are approved substantially equivalent are approved by PMA processby PMA processIn a PMA the sponsor must In a PMA the sponsor must demonstrate that the device is safe demonstrate that the device is safe and effective for intended useand effective for intended use

PMAPMA’’d Devicesd Devices

Less than 2% of submissions Less than 2% of submissions approved via PMA (similar to NDA)approved via PMA (similar to NDA)––Magnetic ResonanceMagnetic Resonance––Bone SonometryBone Sonometry––Diagnostic ultrasound as an aid in Diagnostic ultrasound as an aid in

determining breast malignancydetermining breast malignancy––CAD devicesCAD devices

PMA ContentPMA Content

Indications for useIndications for useDevice descriptionDevice descriptionLaboratory testingLaboratory testingPreclinical studiesPreclinical studiesClinical studiesClinical studiesLabelingLabelingManufacturing (GMP)Manufacturing (GMP)

PMA ProcessPMA Process

Multi discipline reviewMulti discipline review

May be reviewed by FDA advisory panelMay be reviewed by FDA advisory panel

FDA review time = 180 daysFDA review time = 180 days

Data is proprietaryData is proprietary

Routes to MarketRoutes to Market

Premarket SubmissionPremarket Submission–– 501(k)501(k)–– ““Me TooMe Too”” processprocessPremarket Approval ApplicationPremarket Approval Application–– PMAPMA–– Determination of Safety and Determination of Safety and

EffectivenessEffectiveness

Investigational UseInvestigational Use

Safety and effectiveness studies on devices that Safety and effectiveness studies on devices that are not market clearedare not market clearedNeeds IRB approvalNeeds IRB approvalNeeds informed consentNeeds informed consentFDA involvement depends on FDA involvement depends on ““significant risksignificant risk””vs. vs. ““nonnon--significant risksignificant risk””If significant risk = FDA IDE approval needed.If significant risk = FDA IDE approval needed.If not significant risk = Only IRB approval If not significant risk = Only IRB approval neededneeded

Investigational UseInvestigational Use

Investigational studies can be multiInvestigational studies can be multi--phasephaseStudies should be well presentedStudies should be well presented–– Intended indications for useIntended indications for use–– Literature reviewLiterature review–– Scientific basisScientific basis–– Safety issues well understood Safety issues well understood –– Protocol scientifically soundProtocol scientifically sound–– Reasonable study endpointsReasonable study endpoints

PrePre--investigational Contactsinvestigational Contacts

FDA/CDRH will meet with you.FDA/CDRH will meet with you.Meetings early in the development/testing Meetings early in the development/testing stage are desirablestage are desirableMeetings are not depended on Meetings are not depended on ““significant significant riskrisk”” statusstatusWe work on a We work on a ““least burdensomeleast burdensome”” basisbasis

SummarySummary

Extensive sources of information are Extensive sources of information are availableavailableThere are multiple pathways to market There are multiple pathways to market clearanceclearanceFDA decisions are driven by risk and FDA decisions are driven by risk and effectiveness issueseffectiveness issuesContact the appropriate FDA/CDRH Contact the appropriate FDA/CDRH component early in the processcomponent early in the process

FY2004 Submission FeesFY2004 Submission Fees

Fee RatesFee RatesPMAPMA FullFull Sm. Bus.Sm. Bus.

Full FeesFull Fees $206,811$206,811 $78,588$78,588

180180--Day Day SuppsSupps $ 44,464$ 44,464 $16,896$16,896

RealReal--Time Time SuppsSupps.. $ 14,890$ 14,890 $5,658$5,658

510(k)510(k)’’ss $ 3,480$ 3,480 $2,784$2,784

Fee Exemptions and WaiversFee Exemptions and Waivers

First time PMA application from a small First time PMA application from a small business business –– waiverwaiverAny device intended to be used solely for Any device intended to be used solely for pediatric use pediatric use –– exempt from feesexempt from feesState or Federal government applications State or Federal government applications –– exempt from fees (ex for comm. dist.)exempt from fees (ex for comm. dist.)

Small Business = Ann gross revenue Small Business = Ann gross revenue ≤≤ $30M$30M

What the What the ““Critical PathCritical Path”” IsIs

A serious attempt to bring attention & A serious attempt to bring attention & focus to the need for more scientific effort focus to the need for more scientific effort and publiclyand publicly--available information on available information on evaluative toolsevaluative tools

Evaluative toolsEvaluative tools: The techniques & : The techniques & methodologies needed to evaluate the methodologies needed to evaluate the safety, efficacy & quality of medical safety, efficacy & quality of medical devices as they move down the pathdevices as they move down the path

ContactContact

Web Address:Web Address:http://http://www.fda.gov/oc/initiatives/criticalpathwww.fda.gov/oc/initiatives/criticalpath//

Open Docket:Open Docket:http://http://www.fda.gov/dockets/ecommentswww.fda.gov/dockets/ecommentsDocket # 2004NDocket # 2004N--01810181

CDRH webpage (under news and events) CDRH webpage (under news and events) provides links to the critical path white paper provides links to the critical path white paper and docket:and docket:

http://http://www.fda.gov/cdrhwww.fda.gov/cdrh//